đź“‹ FDA Reference
nexsite hd hemodialysis split tip catheter for long term use 24cm nexsite hd hemodialysis split tip catheter for long term use 28cm nexsite hd hemodialysis split tip catheter for long term use 32cm nexsite hd hemodialysis split tip catheter for long term use 36cm nexsite hd hemodialysis split tip catheter for long term use 40cm nexsite hd hemodialysis split tip catheter for long term use 55cm
Marvao Medical Devices
Summary: The NexSite HD Hemodialysis Catheter is a long-term dialysis access device used for hemodialysis in patients with chronic kidney disease. It is typically used by nephrologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K143567 ↗
Decision Date
March 31, 2015
Product Code
MSD
Device Class
Class 2
Evidence
0 studies
The NexSite HD Hemodialysis Catheter was cleared via the FDA 510(k) pathway on March 31, 2015. Manufactured by Marvao Medical Devices, it is classified as a Class 2 device under product code MSD.
What It Is
The NexSite HD Hemodialysis Catheter is a split tip catheter designed for long-term use in hemodialysis. It is inserted into a central vein, typically the internal jugular, to provide reliable vascular access for patients undergoing dialysis. The catheter is available in various lengths to accommodate different patient anatomies and is designed to optimize blood flow while minimizing complications.
Clinical Applications
This catheter is primarily used in the management of end-stage renal disease (ESRD) patients requiring long-term hemodialysis. It is commonly placed in hospital settings by nephrologists or interventional radiologists. The device is suitable for adult patients who need consistent and reliable vascular access for dialysis treatments.
Indications for Use
The NexSite HD Hemodialysis Catheter is indicated for patients who require long-term vascular access for hemodialysis. It is particularly useful for those with chronic kidney disease who are not candidates for arteriovenous fistulas or grafts.
Practical Considerations
The catheter is available in lengths ranging from 24cm to 55cm, allowing for customization based on patient size and vein location. It is important to ensure proper placement and securement to prevent dislodgement and infection. Compatibility with standard dialysis equipment is a key consideration.
Frequently Asked Questions
What is the NexSite HD Hemodialysis Catheter used for?
It is used for providing long-term vascular access for hemodialysis in patients with chronic kidney disease.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device, often in collaboration with interventional radiologists.
What are the FDA-cleared indications?
The device is indicated for patients requiring long-term hemodialysis access, particularly those with chronic kidney disease.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.